Prevalence of Drug-resistant Hiv-1 Strains in Patients Experiencing Virologic Failure. (MULTIVIR2025)

NCT06842706 | Not Yet Recruiting DMC

• 1 other identifier: ANRS0788s MULTIVIR2025
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this cross-sectional, national and multicenter study, the main objective is to determine the prevalence of multi-drug resistant viruses (i.e., viruses that are resistant or possibly resistant to at least one antiretroviral drug from four different therapeutic classes: NRTI, NNRTI, PI, INSTI) among people with HIV 1 (PWH) experiencing virological failure.

Conditions

HIV Infection

Keywords

HIV; drug resistance; antiretrovirals; multi-drug resistant; virological failure

Outcome Measures

Primary Outcomes (1)

• Drug resistance-associated mutations are those defined in the current ANRS algorithm (https://hivfrenchresistance.org/hiv-french-resitance-tables-of-rules/) and in the current Stanford algorithm (http://hivdb.stanford.edu) at the time of analysis.

  Genotypic resistance to an antiretroviral drug will be interpreted using these two algorithms. Resistance to a therapeutic class will be defined as a resistance, or possible resistance, to all drugs in the class.

  Recruitment period: 6 months ·Participation period per participant: 1 day (no follow-up visit) ·Total research period: 12 months · Provisional start date: April 1, 2025 · Provisional end da

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Population of people living with HIV (PLHIV) in virological failure, the proportion of participants with virus resistant or possibly resistant to at least one antiretroviral agent from 4 different therapeutic classes: nucleoside reverse transcriptase inhibitor (NRTI), non-nucleoside reverse trancriptase inhibitor (NNRTI), protease inhibitor (PI) and integrase inhibitor (INSTI).

You may qualify if:

• Patient (male or female) 18 years of age or older.
• Patient who has given his or her consent to participate in the study.
• Patient on antiretroviral therapy for at least six months, with a plasma viral load (VL) greater than 50 copies/mL on at least two consecutive measurements.

You may not qualify if:

• Patients opposed to the use of their data.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Quentin Le Hingrat, DR

  Bichat-Claude Bernard University Hospital, Paris, AP-HP.Nord

  PRINCIPAL INVESTIGATOR

• Constance Delaugerre, PR

  Service de Virologie Hôpital Saint-Louis, AP-HP.Nord 1 avenue Claude Vellefaux, 75010 Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariam GHARIB

CONTACT

0144236442; mariam.gharib@inserm.fr

Quentin Le Hingrat

CONTACT

+33 1 40 25 88 06; quentin.lehingrat@aphp.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 24, 2025
• Study Start: April 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share